Study of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 16, 2023

Primary Completion Date

March 4, 2025

Study Completion Date

June 30, 2027

Conditions
Diffuse Large B-Cell LymphomaHigh-grade B-cell Lymphoma (HGBCL)B-Cell Lymphoma TreatmentRelapsed or Refractory Lymphoma
Interventions
DRUG

Loncastuximab Tesirine (Anti-CD19 Antibody-Drug Conjugate)

Loncastuximab Tesirine is an antibody-drug conjugate specifically targeting CD19, a protein found on the surface of B-cells. It is designed to deliver a cytotoxic pyrrolobenzodiazepine dimer directly to CD19-expressing malignant B-cells. Unlike traditional chemotherapies, Loncastuximab Tesirine combines the precision of an anti-CD19 monoclonal antibody with a potent chemotherapy agent, offering targeted therapy for relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma (HGBCL) after failure of CAR-T therapy. It is administered intravenously every 3 weeks, with an initial higher dose of 150 μg/kg followed by a reduced dose of 75 μg/kg for up to 8 cycles, distinguishing it from other treatments by its specific targeting mechanism and dosage regimen tailored to this patient population.

Trial Locations (7)

12100

RECRUITING

Azienda Sanitaria Ospedaliera Santa Croce e Carle di Cuneo, Cuneo

15121

RECRUITING

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo, Alessandria

20089

RECRUITING

Irccs Istituto Clinico Humanitas, Rozzano

20132

RECRUITING

Ospedale San Raffaele, Milan

20133

RECRUITING

Istituto Nazionale dei Tumori, Milan

40138

RECRUITING

Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna

00161

RECRUITING

AOU Policlinico Umberto I, Roma

All Listed Sponsors
lead

Istituto Clinico Humanitas

OTHER